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Dexmedetomidine vs Lorazepam for Agitation in Schizophrenia or Bipolar Disorder

Phase 4

Recruiting

Research Sponsored by Temple University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized on an inpatient unit at Episcopal Hospital

Meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, as determined by routine clinical assessment conducted upon admission

Must not have

Women who are pregnant or breastfeeding

Participant has mild, moderate or severe hepatic impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 15, 30, 60, 90, and 120 minutes

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares the effects of a drug (dexmedetomidine) to a known drug (lorazepam) in treating agitation in people with schizophrenia or bipolar disorder.

Who is the study for?

Adults aged 18-55 with schizophrenia, schizoaffective disorder, or bipolar disorder experiencing moderate to severe agitation can join. They must be inpatients at Episcopal Hospital, not allergic to the study drugs, and not on high-risk medications or have certain health conditions like severe liver issues or heart problems.

What is being tested?

The trial is testing sublingual dexmedetomidine against lorazepam for calming patients with significant agitation due to mental health conditions. The effectiveness will be measured using specific scales that assess excitement and calmness levels.

What are the potential side effects?

Dexmedetomidine may cause dry mouth, low blood pressure, slow heart rate, and drowsiness. Lorazepam can lead to sedation, weakness, low blood pressure as well but also has a risk of dependence with long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently admitted as an inpatient at Episcopal Hospital.

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I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.

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I am between 18 and 55 years old.

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I am experiencing a moderate to severe episode of agitation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have liver problems.

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I have lung disease and am on treatment like oxygen or inhalers.

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I have had low potassium or magnesium levels in the last 2 years.

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I am currently taking medications that are considered high-risk, such as opioids or drugs that can affect my heart rhythm.

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I am currently taking benzodiazepines or methadone regularly.

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I have a history of heart rhythm problems or a QTc of 500 msec or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 15, 30, 60, 90, and 120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 15, 30, 60, 90, and 120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 15, 30, 60, 90, and 120 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in PANSS-EC score at 120 minutes after medication administration

Secondary study objectives

Assess the need for rescue medication for agitation within two hours of medication administration

Change from baseline in ACES score at 15, 30, 60, 90, and 120 minutes, or prior to receipt of any rescue medication for agitation.

Change in PANSS-EC score at 15, 30, 60, and 90 minutes, or prior to receipt of any rescue medication for agitation.

+2 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613

57%

Clinically important hypotension

Clinically important bradycardia

infection

stroke

Atelectasis

Hemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Dexmedetomidine

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DexmedetomidineExperimental Treatment1 Intervention

Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed.

Group II: LorazapemActive Control1 Intervention

Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine

2015

Completed Phase 4

~2050

0 / 11Eligibility criteria met